Osteopathic Sympathetic Harmonization and Depression

NCT ID: NCT04840043

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-11
• Study Completion Date: 2018-06-05

Brief Summary

Depression appears to be resistant to the available pharmacological treatments. Autonomic responses accompanied by any psychological stress are sympathetic nervous system (SNS) and neuroendocrine responses are formed by hypothalamus-pituitary-adrenal (HPA) axis. The purpose of this study is; assessment of effectiveness of osteopathic approach on sympathetic nervous system and HPA axis in adolescents with depression.

Detailed Description

Depression diagnosed and volunteer to participate 39 cases who between the ages of 15-21 included. All participants were recruited and randomly assigned into two groups, the osteopathy group (OG) and the placebo group (PG). Stimulation on the sympathetic truncus and prevertebral ganglia were performed in the OG group. The stimulation of the PG group was performed with a lighter touch and a shorter duration in similar areas. Each participant was filled in the demographic data form, Beck Depression Scale and State and Trait Anxiety Inventory (STAI Form - 1 and Form - 2) before the application. Emotional state visual analog scale and STAI Form - 1 was filled and blood pressure and pulse measurement were made and saliva sample was taken before application, immediately after application and 20 minutes after application.

Conditions

Osteopathic Manipulative Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Osteopathy Group

Stimulation on the sympathetic truncus and prevertebral ganglia

Group Type: EXPERIMENTAL

Osteopathic sympathic harmonization

Intervention Type: OTHER

Treatments that harmonize at the sympathetic nerves or plexus, e.g., sympathetic trunk stimulation by means of the rib-raise technique or stimulation of the prevertebral ganglia.

Control Group

Stimulation on similar areas with lighter touch and shorter duration

Group Type: SHAM_COMPARATOR

Sham intervention

Intervention Type: OTHER

Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.

Interventions

Osteopathic sympathic harmonization

Treatments that harmonize at the sympathetic nerves or plexus, e.g., sympathetic trunk stimulation by means of the rib-raise technique or stimulation of the prevertebral ganglia.

Intervention Type: OTHER

Sham intervention

Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• To be diagnosed with clinical depression by a psychiatrist according to The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
• Volunteering to participate in the study

Exclusion Criteria

• Fever over 38.5
• Acute injury or infection
• Rib fracture
• Cardiac arrhythmia
• Using drugs that affect cortisol levels (oral contraceptives, hormonal drugs, antidepressants, antipsychotics etc.)
• Being pregnant, premenstrual or in the menstrual period for female participants

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Ömer Osman PALA

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omer Osman PALA, PhD

Role: STUDY_DIRECTOR

Cumhuriyet University, Faculty of Health Sciences, Physiotherapy and Rehabilitation

Seyit CITAKER, Prof

Role: PRINCIPAL_INVESTIGATOR

Gazi University, Faculty of Health Sciences, Physiotherapy and Rehabilitation

Esra GUNEY, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Gazi University, Faculty of Medicine, Child and Adolescent Psychiatry

Aylin SEPICI DINCEL, Prof

Role: PRINCIPAL_INVESTIGATOR

Gazi University, Faculty of Medicine, Medical Biochemistry

Güner Melike GUVELI, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University, Faculty of Medicine, Child and Adolescent Psychiatry

Burak ARSLAN, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University, Faculty of Medicine, Medical Biochemistry

Locations

Sivas Cumhuriyet University

Sivas, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30.

Reference Type: BACKGROUND

PMID: 20606239 (View on PubMed)

Pala OO, Citaker S, Guney E, Sepici A, Guveli GM, Arslan B, Guru M. Effectiveness of osteopathic manipulative applications on hypothalamic-pituitary-adrenal (HPA) axis in youth with major depressive disorder: a randomized double-blind, placebo-controlled trial. J Osteopath Med. 2024 Feb 29;124(6):267-275. doi: 10.1515/jom-2023-0056. eCollection 2024 Jun 1.

Reference Type: DERIVED

PMID: 38414339 (View on PubMed)

Other Identifiers

E-16-1106

Identifier Type: -

Identifier Source: org_study_id